Trial Outcomes & Findings for Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825) (NCT NCT00364286)
NCT ID: NCT00364286
Last Updated: 2023-12-19
Results Overview
Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: \> 50% decrease; Liver/Spleen CR: Not palpable; PR: \> 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: \>1,500/μl, PR: \> 1,500/μl or \>50% improvement from baseline; Platelets for CR: \>100,000/μl, PR: \>100,000/μl or \> 50% improvement from baseline; Hemoglobin (untransfused) for CR: \>11,0 g/dl; PR: \>11.0 g/dl or \>50% improvement from baseline; Lymphocytes for CR: \<4,000/μl and PR: \>50% decrease; Bone Marrow aspirate for CR: \<30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: \< 30% lymphocytes with residual disease on biopsy for nodular PR.
COMPLETED
PHASE2
17 participants
up to 3 months
2023-12-19
Participant Flow
Recruitment Period: 8/14/2006 through 11/28/2012. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Dasatinib
Dasatinib 50mg Orally twice daily.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Dasatinib
Dasatinib 50mg Orally twice daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
Baseline characteristics by cohort
| Measure |
Dasatinib
n=17 Participants
Dasatinib 50mg Orally twice daily.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 monthsPopulation: Three participants were not evaluable for response due to early discontinuation of treatment (0-3 days).
Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: \> 50% decrease; Liver/Spleen CR: Not palpable; PR: \> 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: \>1,500/μl, PR: \> 1,500/μl or \>50% improvement from baseline; Platelets for CR: \>100,000/μl, PR: \>100,000/μl or \> 50% improvement from baseline; Hemoglobin (untransfused) for CR: \>11,0 g/dl; PR: \>11.0 g/dl or \>50% improvement from baseline; Lymphocytes for CR: \<4,000/μl and PR: \>50% decrease; Bone Marrow aspirate for CR: \<30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: \< 30% lymphocytes with residual disease on biopsy for nodular PR.
Outcome measures
| Measure |
Dasatinib
n=14 Participants
Dasatinib 50mg Orally twice daily.
|
|---|---|
|
Participants With Objective Response
Complete Response (CR)
|
0 Participants
|
|
Participants With Objective Response
Partial Response (PR)
|
1 Participants
|
|
Participants With Objective Response
No Objective Response
|
13 Participants
|
Adverse Events
Dasatinib
Serious adverse events
| Measure |
Dasatinib
n=17 participants at risk
Dasatinib 50mg Orally twice daily.
|
|---|---|
|
Infections and infestations
Infection
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
Other adverse events
| Measure |
Dasatinib
n=17 participants at risk
Dasatinib 50mg Orally twice daily.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
76.5%
13/17 • Number of events 13 • 6 Years, 3 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
41.2%
7/17 • Number of events 7 • 6 Years, 3 Months
|
|
Blood and lymphatic system disorders
Anemia
|
82.4%
14/17 • Number of events 14 • 6 Years, 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.9%
1/17 • Number of events 1 • 6 Years, 3 Months
|
|
General disorders
flushing
|
35.3%
6/17 • Number of events 6 • 6 Years, 3 Months
|
|
General disorders
Headache
|
35.3%
6/17 • Number of events 6 • 6 Years, 3 Months
|
|
General disorders
Fatigue
|
41.2%
7/17 • Number of events 7 • 6 Years, 3 Months
|
|
Gastrointestinal disorders
Anorexia
|
47.1%
8/17 • Number of events 8 • 6 Years, 3 Months
|
|
Gastrointestinal disorders
Nausea
|
47.1%
8/17 • Number of events 8 • 6 Years, 3 Months
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
4/17 • Number of events 4 • 6 Years, 3 Months
|
Additional Information
Susan O'Brien, MD/ Professor
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place